SolitaireTM

GUDID 00847536020528

STENT SFR3-4-20-10V01 US

Micro Therapeutics, Inc.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 00847536020528
• NIH Device Record Key: 580b85e2-163e-4069-9d06-8f89ab540bef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SolitaireTM
• Version Model Number: SFR3-4-20-10
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536020528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153071

FDA Product Code

• NRY: CATHETER, THROMBUS RETRIEVER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-28

On-Brand Devices [SolitaireTM]

• 00847536027060: STENT SFR3-6-24-06 V01
• 00847536027053: STENT SFR3-4-20-05 V01
• 00847536020559: STENT SFR3-6-40-10V01 US
• 00847536020542: STENT SFR3-6-20-10V01 US
• 00847536020535: STENT SFR3-4-40-10V01 US
• 00847536020528: STENT SFR3-4-20-10V01 US